FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956237315
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA23LAVDC
Catalog number
SBA23LAVDC
Device description
LAPAROSCOPY PACK
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956237313PackageGS12In Commercial Distribution
10198956237315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895623731350198956237313
1019895623731510198956237315

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS187280Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-22
10198956388888CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956494701CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956515680CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956516939CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956521681CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956532588CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956458987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956513099CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956528499CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956531239CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
B098AMS184440Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-12
10198956395039CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956493599CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956509337CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956512672CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956514416CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956527041CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956503618CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-06
B098AMS15230A0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-06-25
10198956374119CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956387171CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956456778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956488137CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956495968CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496279CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496620CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956339392CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956376748CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956475502CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05